The steps involved in identifying the 63 ODs for this study.
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a. The list of 862 ODs approved in the US between 1 January 1983 and 17 April 2020, inclusive, obtained from FDAOD. b. The list of the 862 ODs’ 552 unique trade names, and their break up into (i) 413 with single approvals, (ii) 139 with multiple approvals, and (iii) 40 cases with trade names unavailable. c. Of the 413 single approval trade names, 123 had a single mention in the Orange Book, and 290 either did not have any mention in the Orange Book or had multiple mentions in it. d. Of the 123 ODs with a single occurrence in the Orange Book, 72 were approved after 31 Dec 2008. e. Of the 72 ODs approved after 31 Dec 2008, 63 had publicly available FDA documents such as the Medical Review. f. The list of 63 ODs, with their year of marketing approval and the FDA document consulted for this study. g. From 2009–2020, per year (i) the number of ODs in this study, (ii) the percentage of ODs, out of 63 (iii) the percentage, in 3-year segments. (XLS)
创建时间:
2022-08-15



